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Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
amifostine trihydrate
cytarabine
topotecan hydrochloride
Sponsored by
ALZA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following: Bilineage cytopenia Unfavorable cytogenetic abnormalities Refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast) At least 0.5 on the International Prognostic Score System No chronic myelomonocytic leukemia No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%) PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count less than 1,500/mm3 Platelet count less than 100,000/mm3 Hemoglobin less than 10 g/dL Hepatic: ALT less than 5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception Must have right atrial catheter inserted PRIOR CONCURRENT THERAPY: Biologic therapy: No prior blood or bone marrow transplantations Chemotherapy: No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine) No prior topotecan No prior amifostine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 24 hours since prior antihypertensive medication prior to amifostine

Sites / Locations

  • Cancer Center and Beckman Research Institute, City of Hope

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
ALZA
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1. Study Identification

Unique Protocol Identification Number
NCT00003827
Brief Title
Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Official Title
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ALZA

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.
Detailed Description
OBJECTIVES: Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome. Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen. Determine the duration of response and time to disease progression following this treatment regimen in these patients. OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first. Patients are followed at least monthly for 2 years, then every 3-6 months until death. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following: Bilineage cytopenia Unfavorable cytogenetic abnormalities Refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast) At least 0.5 on the International Prognostic Score System No chronic myelomonocytic leukemia No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%) PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count less than 1,500/mm3 Platelet count less than 100,000/mm3 Hemoglobin less than 10 g/dL Hepatic: ALT less than 5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception Must have right atrial catheter inserted PRIOR CONCURRENT THERAPY: Biologic therapy: No prior blood or bone marrow transplantations Chemotherapy: No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine) No prior topotecan No prior amifostine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 24 hours since prior antihypertensive medication prior to amifostine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry C. Fung, MD, FRCPE
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

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